VI. Regulatory Process Matters

A. Final Regulatory Assessment (EO 13563 and EO 12866)

Executive Orders 13563 and 12866 direct agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Important goals of regulatory analysis are to (1) establish whether federal regulation is necessary and justified to achieve a market failure or other social goal and (2) demonstrate that a range of reasonably feasible regulatory alternatives have been considered and that the most efficient and effective alternative has been selected. Executive Order 13563 also recognizes that some benefits are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively those values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.

The final rule, which sets forth the MDE Standards, is a significant regulatory action within the meaning of Executive Order 12866. See E.O. 12866 § 3(f)(4), 58 FR 51735 (Oct. 4, 1993) (defining “significant regulatory action” as, among other things, regulatory action that raises novel legal or policy issues). Accordingly, we prepared a final regulatory assessment (Final RA) to accompany the MDE Standards. The Final RA is available on the Access Board’s website (www.access-board.gov), as well the federal government’s online rulemaking portal (www.regulations.gov). Summarized below are some of the key findings of this regulatory assessment.

Section 510 of the Rehabilitation Act, as amended by the Patient Protection and Affordable Care Act, requires the Access Board, in coordination with the Food and Drug Administration, to issue accessibility standards that contain minimum technical criteria to ensure that medical diagnostic equipment is accessible to and usable by patients with disabilities. Examples of such diagnostic equipment include examination tables and chairs, weight scales, mammography equipment, and other imaging equipment. The Access Board is now issuing the final rule pursuant to this authority.

The MDE Standards set forth minimum technical criteria for medical diagnostic equipment to facilitate access and use of medical diagnostic equipment by persons with disabilities, most particularly those with mobility- or communication-related impairments. However, under Section 510, the Access Board is statutorily tasked only with promulgation (and revision) of these Standards. Although the MDE Standards do not have legal effect until adopted (in whole or in part) by an enforcing authority, they can advance accessibility to medical services for persons with disabilities by providing specific guidance concerning accessible medical diagnostic equipment that can be used by service providers in a voluntary manner.

At this point, the Board does not know whether enforcing authorities will adopt the MDE Standards, nor (if they do) to what extent health care practices or particular types of medical diagnostic equipment will be required to comply with the Standards’ technical requirements. For this reason, the Board cannot estimate the incremental monetary or quantitative impacts of the final rule.

Nevertheless, the Board is able to characterize qualitatively some of the potential impacts of these Standards. If enforcing agencies adopt the MDE Standards as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers, medical device manufacturers, and individuals with disabilities. Once health care providers and facilities are required to acquire accessible medical equipment, they could incur compliance costs, to the extent that their equipment is not already accessible. Medical device manufacturers would then decide whether to incur incremental costs to meet the demand for accessible equipment, and some or many manufacturers may have an economic incentive to produce accessible equipment. Finally, given the many barriers to health care that patients with disabilities encounter due to inaccessible medical diagnostic equipment, individuals with mobility and communication disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. Consequently, they may be able to receive health care comparable to that received by their non-disabled counterparts.

In addition, the Standards could yield some immediate benefits, even before any adoption by implementing agencies in formal rulemaking. First, the technical specifications for accessible MDE incorporated in the Standards will benefit enforcing agencies that are considering similar accessibility requirements for entities under their jurisdiction. Although enforcing agencies have full authority over whether to adopt the Access Board’s final rule (in whole or in part), the technical specifications in the MDE Standards reflects the input from a diverse set of stakeholders and provide solid groundwork for any future rulemaking pertaining to the accessibility of medical diagnostic equipment. Second, the Standards will serve as a best-practice document for the medical device industry and for health care providers and facilities. While the MDE Standards are non-binding, health care providers can use this final rule as guidance on how to provide equitable access to medical diagnostic equipment for people with mobility and communication disabilities. Manufacturers can also use the MDE Standards as they target their research and development efforts at producing diagnostic equipment that can be used by a larger segment of population – one that includes more people with disabilities and older adults.

The Board thus concludes that the potential benefits of the MDE Standards justify the potential costs; that the MDE Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) requires federal agencies to analyze the impact of regulatory actions on small entities, unless an agency certifies that the rule will not have a significant impact on a substantial number of small entities. 5 U.S.C. 604, 605 (b). The MDE Standards do not impose any mandatory requirements on any entity, including small entities. Therefore, we did not prepare a final regulatory flexibility analysis for the final rule.

C. Executive Order 13132: Federalism

The MDE Standards do not impose any mandatory requirements on state and local governments. The MDE Standards do not have any direct effects on the state governments, the relationship between the national government and state governments, or the distribution of power and responsibilities among the various levels of government. The MDE Standards do not preempt state law. Therefore, the consultation and other requirements of Executive Order 13132 (Federalism) do not apply.

D. Unfunded Mandates Reform Act

The proposed standards do not impose any mandatory requirements on state, local, or tribal governments or the private sector. Therefore, the Unfunded Mandates Reform Act does not apply.

E. Paperwork Reduction Act

Under the Paperwork Reduction Act (PRA), federal agencies are generally prohibited from conducting or sponsoring a “collection of information: as defined by the PRA, absent OMB approval. See 44 U.S.C. 3507 et seq. The MDE Standards do not impose any new or revised collections of information within the meaning of the PRA.